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The FDA accepts legal aid from Pfizer and delays releasing licensure pages till May

Published: February 2, 2022 | Print Friendly and PDF
  Gab
 

Source: lynnwood times

As the Lynnwood Times reported previously, Federal Judge Mark T. Pittman of the US District Court for the Northern District of Texas ordered the Food and Drug Administration (FDA) to accelerate the release of an estimated 451,000 pages of material related to the licensing of Pfizer’s COVID-19 vaccine on January 6, 2022.

The FDA must produce “more than 12,000 pages” on or before January 31, 2022. From there, the administration is required to produce “the remaining documents at a rate of 55,000 pages every 30 days, with the first production being due on or before March 1, 2022, until production is complete,” according to the court order.

Most recently, however, the FDA has asked the court to delay making the first round of 55,000 pages public till May 2022. The FDA has also accepted legal aid from Pfizer.

FDA’s push back due to staffing issues

Pushback from the FDA has primarily focused on staffing issues. As Reuters reported on January 7, “The FDA didn’t dispute it had an obligation to make the information public but argued that its short-staffed FOIA office only had the bandwidth to review and release 500 pages a month.”

According to court documents, the FDA originally only “allocated the equivalent of nearly 11 full-time staff to this project.” 

Then, to meet the demand of reviewing so many papers, “The FDA […] plans to hire 15 contractors, ‘detail’ 8 agency employees, and assign 5.5 of its normal review staff to the project, for a total of 28.5 reviewers.” It seems a daunting task, then, to have less than 30 workers review 55,000 pages in one month.

As a result, the FDA “insists it must delay its first 55,000-page production until May 1, 2022 – four months after the Court entered its order.” 

However, the FDA received Pfizer’s Biologics License Application (BLA) in May of 2021, which, again, included more than 450,000 pages, and was able to review and approve the application by August that same year according to the administration’s approval letter. To accomplish this task, the FDA would have had to examine roughly 112,500 pages a month.

On January 21, the FDA accepted Pfizer’s legal aid. The pharmaceutical company persisted its involvement would be necessary to prevent exposing trade secrets and confidential commercial information to the public.

As the court document states, “due to the unprecedented speed with which the Court has ordered FDA to process the records at issue, FDA anticipates that coordination with Pfizer to obtain the company’s views as to which portions of the records are subject to Exemption 4, the Trade Secrets Act (“TSA”), 18 U.S.C. § 1905, or other statutory protections will be a necessary component of the agency’s endeavors to meet the extraordinary exigencies of this case.”

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